Last reviewed 2026-04-20 · How we verify

Cefcamate (CEFCAPENE)

Phase 2 active Small molecule

Cefcamate (generic name: CEFCAPENE) is a cefcapene drug. It is currently in Phase 2 development.

Cefcapene works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

Cefcapene (CEFCAPENE) is a small molecule antibiotic belonging to the cefcapene class. It is a third-generation cephalosporin antibiotic, but its exact target and mechanism of action are not well-documented. The current owner of Cefcapene is not specified, and its commercial status, including FDA approval and off-patent status, is unknown. Further research is needed to determine its approved indications, half-life, and bioavailability.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	CEFCAPENE
Drug class	cefcapene
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall as a strong, protective shield. Cefcapene blocks the enzymes that help build and repair this shield, causing the bacteria to weaken and eventually die. This allows the body's immune system to fight off the infection more effectively.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cefcamate CI brief — competitive landscape report
Cefcamate updates RSS · CI watch RSS

Frequently asked questions about Cefcamate

What is Cefcamate?

Cefcamate (CEFCAPENE) is a cefcapene drug.

How does Cefcamate work?

Cefcapene works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

What is the generic name of Cefcamate?

CEFCAPENE is the generic (nonproprietary) name of Cefcamate.

What drug class is Cefcamate in?

Cefcamate belongs to the cefcapene class. See all cefcapene drugs at /class/cefcapene.

What development phase is Cefcamate in?

Cefcamate is in Phase 2.

Drug class: All cefcapene drugs
Therapeutic area: All drugs in Infectious Disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing